Competencies Consulting Services
Quality Management
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Improved study performance and results with our Quality Management System.
Quality is a significant topic and it is heavily integrated into all our clinical and business practices. Accelsiors provides oversight of the Quality Management System (QMS) and as part of our commitment to continual improvement, we measure, assess and report quality data while seeking ways to continually improve performance and results.
Our team of professionals interacts directly with clients to understand the specific requirements for their clinical study or related service. Accelsiors’ Quality and Regulatory Affairs Specialists oversee compliance with Customer, the United States Food and Drug Administration (FDA) regulations, European Union directives & regulations, and other applicable international agencies’ regulations during each phase of a given study.
Our experience and oversight ensure that all our services comply with applicable Good Clinical Practices (GCP), and International Conference on Harmonization (ICH) guidelines.
Our procedures for planning, conducting, and reporting audits, facilitating and follow-up of regulatory inspections and overseeing Serious Quality Issues lead to a robust corrective and preventive action (CAPA) process. This combination of processes ensures that we identify significant quality issues in time, report the findings/conclusions, document and implement corrective / preventive actions before any mistake could evolve into a study risk.
Key QM services:
- Study risk-assessments
- Independent audits of investigator sites
- Independent audits of vendors
- Process/system audits
- Pre-inspection audits
- Inspection support activities
Proactively improved study quality, outcomes and performance by focusing more on what critically matters for the success
The integration of quality into all of our practices is an essential element of our Accelerated Delivery Solution. With our QualityDrive™ – a Quality by Design – approach we help to build quality into your clinical trial from the beginning, and assist you to detect and focus the right efforts on the areas of highest risk of generating errors that matter most for the success of the study.
Let us accelerate your clinical drug development program!
Are you interested in learning more about how Accelsiors can create solutions to help you accelerate your clinical trials? Our team is ready to answer your questions. Get in touch with our experienced drug development experts!